NCT01730794

Brief Summary

The purpose of this study is to compare a specific mode of artificial ventilation (help from a breathing machine) with other modes. This specific mode is called Neurally Adjusted Ventilatory Assist (NAVA) and is different from other modes as it uses direct signals from the diaphragm (breathing muscle) to help patients breathe. The investigators believe that using these signals, NAVA can determine the exact timing for patients' spontaneous breathing effort and delivers the artificial breath at the same time (in synchrony) with their own breath. Other modes (breathing methods) may cause asynchrony between the patient and the ventilator while delivering artificial breaths because of the way they operate. Asyncrony between patient and ventilator is a risk factor for increasing the length of artificial ventilation and number of related complications. The investigators would like to find out if NAVA performs better in establishing synchrony between patient and ventilator and as a result decreasing time for artificial ventilation and increasing better outcomes.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
306

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
2 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 28, 2014

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

5.8 years

First QC Date

November 15, 2012

Last Update Submit

January 23, 2020

Conditions

Acute Respiratory Failure

Keywords

Acute Respiratory FailureMechanical VentilationNAVALung protective ventilationinvasive ventilationnoninvasive ventilation

Outcome Measures

Primary Outcomes (1)

  • Number of invasive ventilator free days.

    Number of days without mechanical ventilation, within the first 28 days of the study.

    28 days

Secondary Outcomes (7)

  • Total length of mechanical ventilation in survivors (invasive plus noninvasive)

    90 days

  • ICU and hospital Mortality

    90 days

  • Incidence of barotrauma

    60 Days

  • Ventilator associated pneumonia

    60 Days

  • Development of Acute respiratory distress syndrome (ARDS)

    60 Days

  • +2 more secondary outcomes

Study Arms (2)

Conventional Lung Protective Ventilation

OTHER

In this group, patients will be ventilated in either volume A/C, pressure A/C, pressure support, pressure regulated volume control or volume support based on the discretion of the medical team with TV 4-8 ml/kg PBW range and PP or pressure (control or support) level \<30 cmH2O.

Other: Conventional Lung Protective Ventilation

NAVA Ventilation Group

OTHER

In the NAVA group, NAVA level will be set initially at zero, then the maximum Edi will be determined as the average level over the next 3 to 5 breaths without ventilatory support or PEEP. The actual NAVA level will then be titrated by the clinician to achieve the following: 1) an Edi equal to approximately 50% of the maximum Edi, 2) an average tidal volume of between 4 to 8 ml/kg predicted body weight (PBW), and 3) an average respiratory rate between about 15 and 40 per minute. In addition, the trigger sensitivity should be set as sensitive as possible without causing auto-triggering and the maximum pressure limit in NAVA should be set at 40 cm H2O.

Other: NAVA ventilation

Interventions

NAVA ventilationOTHER

Neurally adjusted ventilatory assist

NAVA Ventilation Group
Conventional Lung Protective VentilationOTHER

conventional protective mechanical ventilation

Conventional Lung Protective Ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than or equal to 18 years
  • Hypoxemic or hypercapnic acute respiratory failure
  • Intubation and mechanical ventilation
  • Anticipated mechanical ventilation equal or longer than 72 hrs
  • Mechanically ventilated less or equal to 5 days
  • Able to spontaneously trigger the ventilator

You may not qualify if:

  • moderate-to-severe acute respiratory distress syndrome
  • Post-operative patient's normally requiring a short course of mechanical ventilation (for example most cardiac surgical patients)
  • Unable to spontaneously breathe
  • Need to provide controlled ventilation
  • Poor short term prognosis (defined as a high risk of death in the next 3 months)
  • Neuromuscular or neurologic disease
  • Age \< 18 years
  • Patients with major esophageal, gastric and oral surgery
  • Acute brain injury or elevated intracranial pressure (\> 18 mmHg)
  • Severe cardiac disease: New York Heart Association class 3 or 4 or acute coronary syndrome or persistent ventricular tachyarrhythmias.
  • Pregnancy, must be confirmed by laboratory analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Nanjing Zhongda Hospital Southeast University

Nanjing, China

Location

Hospital Universitario NS de Candelaria

Santa Cruz de Tenerife, Tenerife, 38010, Spain

Location

Hospital NS del Prado

Talavera de la Reina, Toledo, 45600, Spain

Location

Complejo Hospitalario Universitario de Albacete

Albacete, 02006, Spain

Location

Hospital Virgen de la Luz

Cuenca, 16002, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Morales Meseguer

Murcia, 30008, Spain

Location

Hospital Universitario Virgen de Arrixaca

Murcia, 30120, Spain

Location

Hospital Virgen de la Salud

Toledo, 45004, Spain

Location

Hospital Clinico de Valencia

Valencia, Spain

Location

Hospital Universitario Rio Hortega

Valladolid, 47012, Spain

Location

Hospital Txagorritxu

Vitoria-Gasteiz, Álava, 01007, Spain

Location

Related Publications (1)

  • Villar J, Belda J, Blanco J, Suarez-Sipmann F, Anon JM, Perez-Mendez L, Ferrando C, Parrilla D, Montiel R, Corpas R, Gonzalez-Higueras E, Pestana D, Martinez D, Fernandez L, Soro M, Garcia-Bello MA, Fernandez RL, Kacmarek RM; NAVa In Acute respiraTORy failure (NAVIATOR) Network. Neurally adjusted ventilatory assist in patients with acute respiratory failure: study protocol for a randomized controlled trial. Trials. 2016 Oct 13;17(1):500. doi: 10.1186/s13063-016-1625-5.

    PMID: 27737690DERIVED

Study Officials

  • Robert M Kacmarek, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Jesus Villar, MD, PhD

    Hospital Universitario Dr. Negrín, Las Palmas de Gran Canaria, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesia, Director of Respiratory Care Services

Study Record Dates

First Submitted

November 15, 2012

First Posted

November 21, 2012

Study Start

March 28, 2014

Primary Completion

January 22, 2020

Study Completion

January 22, 2020

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

ES(13)CN(1)